BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA PLUS TEST STRIPS

    MDR report key: 10114767 · Received June 3, 2020

    Report

    Report Number
    3011393376-2020-01946
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 7, 2020
    Report Date
    August 6, 2020
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    NBW
    UDI-DI
    00365702407107
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 79 MG/DL AND 179 MG/DL. IT WAS ALSO REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES ON (B)(6) 2020: 179 MG/DL, 229 MG/DL, 162 MG/DL AND 54 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579345 ACCU-CHEK AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIABETES CARE, INC. 06908217001 498124 00365702407107

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR UNKNOWN HEART MEDICATION| UNKNOWN HEART MEDICATION